Impact of the Number of Doses of Antenatal Corticosteroid Therapy on the Number of Doses of Surfactants Postnatal in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Assessment of the effect of a full course of antenatal corticosteroid therapy versus a half course on the number of postnatal surfactant doses in preterm infants.
研究概览
简要总结
No study has shown that two doses of corticosteroids are more effective than a single dose in lung maturation and prevention of hyaline membrane disease (HMD) The aim of this study is to assess the impact of the number of doses on the severity of HMD.
详细描述
Respiratory distress syndrome (RDS), formerly known as hyaline membrane disease, is a common problem in preterm infants. This disorder is caused primarily by deficiency of pulmonary surfactant in an immature lung. RDS is a major cause of morbidity and mortality in preterm infants.
Surfactant therapy has been shown to significantly reduce neonatal and infant mortality. Corticosteroids are given antenatal, and then surfactant is given, along with corticosteroids, postnatal.
A single course of corticosteroids is recommended for pregnant women between 24 weeks and 34 weeks of gestation who are at risk of preterm delivery within 7 days, including those with ruptured membranes and multiple pregnancies.
Betamethasone is recommended as the steroid of choice, to be administered in two doses of 12 mg given intramuscularly 24 hours apart.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants ≤ 37 SA
- •Hospitalized in the neonatal intensive care unit between January 2018 and December 2019
- •Having received at least one dose of corticosteroids antenatal
排除标准
- •Parental Opposition
- •Congenital malformations that may cause neonatal respiratory distress.
结局指标
主要结局
Assessment of the effect of a full course of antenatal corticosteroid therapy versus a half course on the number of postnatal surfactant doses in preterm infants.
时间窗: At the end of the study, an average of 2 month
Comparison of the number of doses of surfactants administered postnatal in preterm infants who received 2 doses of antenatal corticosteroid therapy versus those who received a single dose
次要结局
- Assessment of the influence of the cause of prematurity on the severity of hyaline membrane disease (HMD)(At the end of the study, an average of 2 month)
- Assessment of the influence of gestational age on the severity of hyaline membrane disease (HMD)(At the end of the study, an average of 2 month)
- Assessment of the impact of the number of doses of antenatal corticosteroid therapy on the use of postnatal corticosteroid therapy(At the end of the study, an average of 2 month)
- Assessment of the impact of the number of doses of antenatal corticosteroid therapy on the severity of intraventricular hemorrhage(At the end of the study, an average of 2 month)
- Assessment of the impact of the number of doses of antenatal corticosteroid therapy on the prevalence of bronchopulmonary dysplasia(At the end of the study, an average of 2 month)